The Recall Desk

State

American Samoa product recalls

73,100 recalls have nationwide distribution and so reach American Samoa. 25 additional recalls listed American Samoa specifically in their distribution scope.

What the numbers show

Total
25
Critical
1
Severe
5
Most recent
2026-09-09

Of the 25 recalls naming American Samoa we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (20%) are Severe.

Which agencies issued them

These figures cover only the 25 recalls whose distribution notice names American Samoa specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

11626–11650 of 73125

  • HighFDA (Devices)·Z-1558-2024·2024-04-24

    Philips Evolution 3.0T MRI System patient table floor plate installation defect

    Philips Evolution 3.0T MRI systems may have an incorrectly installed patient support table floor plate, creating a potential safety risk. Affected facilities should verify proper installation.

    Product
    Evolution Upgrade 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.

    Product
    GYROSCAN ACS-NT, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2024·2024-04-24

    Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

    Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

    Product
    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.

    Product
    Intera CV, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2024·2024-04-24

    Philips MRI System Patient Support Table Floor Plate Installation Issue

    Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.

    Product
    Intera 3.0T Quasar Dual, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2024·2024-04-24

    Siemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results

    Siemens Atellica CH and CI analyzers may produce falsely elevated cholesterol and lipid test results (2–16% high) after iron tests. This affects clinical calibration, quality control checks, and patient test results.

    Product
    Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2024·2024-04-24

    Philips Intera 0.5T MRI System Patient Table Floor Plate Installation Defect

    Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.

    Product
    Intera 0.5T Standard, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2024·2024-04-24

    Philips Intera 1.5T MRI Patient Support Table Floor Plate Installation Defect

    Philips is recalling 46 units of the Intera 1.5T Achieva Nova MRI system due to improper installation of the patient support table floor plate. The defect may compromise patient safety during use.

    Product
    Intera 1.5T Achieva Nova, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2024·2024-04-24

    Philips Achieva 1.5T MRI Systems Recalled Due to Incorrect Support Table Installation

    Philips is recalling 1,921 Achieva 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.

    Product
    Achieva 1.5T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2024·2024-04-24

    Philips Intera 1.5T MRI System Patient Support Table Installation Defect

    Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect patient safety.

    Product
    Intera 1.5T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2024·2024-04-24

    MRI System Patient Support Table Floor Plate Installation Defect

    Philips Intera 1.0T MRI systems may have an incorrectly installed patient support table floor plate. This defect could affect patient safety during magnetic resonance imaging procedures.

    Product
    Intera 1.0T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2024·2024-04-24

    CryoValve SG Heart Valve Recalled for Staphylococcus aureus Contamination

    Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.

    Product
    CryoValve SG Cryopreserved Pulmonary Human Heart Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2024·2024-04-24

    MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.

    Product
    Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring

    Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2024·2024-04-24

    SW Bari Lift & Transfer Device Recalled Due to Weight and Safety Defects

    Raye's Inc. is recalling the SW Bari Lift & Transfer (Model 38060000) due to two critical defects: it cannot safely support its maximum rated weight, and it lacks a safety mechanism to prevent falls during a single equipment failure.

    Product
    SW Bari Lift & Transfer, Model Number 38060000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2024·2024-04-24

    Microalbumin Calibrator Series Recall Due to Measurement Accuracy Issue

    FDA recalls Microalbumin Calibrator Series due to negative measurement bias that may misclassify patient results. Laboratories using affected batches should review quality control data and consider recalibration.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2024·2024-04-24

    Magnetic Resonance System Patient Support Table Floor Plate Installation Issue

    Philips is recalling the MR 7700 Magnetic Resonance System due to potential incorrect installation of the patient support table floor plate. The recall affects 26 units distributed worldwide.

    Product
    MR 7700, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2024·2024-04-24

    Gastrointestinal Suture Anchor Recalled Due to Packaging Seal Defect

    Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.

    Product
    Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1567-2024·2024-04-24

    MRI System Patient Support Table Floor Plate Installation Defect

    Philips Ingenia 3.0T CX MRI systems may have an incorrectly installed patient support table floor plate. This installation error could compromise the stability of the patient support table during use.

    Product
    Ingenia 3.0T CX, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2024·2024-04-24

    Conformis Identity Imprint PS Tibial Tray Size 4 Packaging Error

    Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.

    Product
    Identity Imprint PS Tibial Tray Size 4: Lot 540287
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2024·2024-04-24

    Philips Intera 1.5T MRI System Patient Support Table Floor Plate Installation Defect

    Philips is recalling Intera 1.5T magnetic resonance systems worldwide because the patient support table floor plate may be incorrectly installed, potentially affecting table stability and patient safety.

    Product
    Intera 1.5T Power/Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2024·2024-04-24

    Microalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification

    Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2024·2024-04-24

    Philips Achieva 3.0T MRI System Patient Support Table Floor Plate Installation Defect

    Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.

    Product
    Achieva 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide